Have you ever seen the movie, Groundhog Day? If so, that is the best way to describe what some might compare to that of a researcher. For those of you that have not watched the movie, it’s about a weatherman stranded in a town he loathes and wakes up with the strangest sense of déjà vu: he seems to be living the same day over again. The next morning it happens again, and then again. In the end, the character Phil Connors, played by Bill Murray, gets time to really examine his life and he begins to change mostly because he keeps getting chances to do things over. He eventually gets it right.
In the drug development industry, one might say we repeat the same redundant process of evaluating drugs, going through preclinical stages and then clinical stages. The real backbreaker is the fact that 95% of the experimental medicines studied in humans fail to be both effective and safe, so eventually, the research repeats itself. One could find themselves in the same shoes as Phil Connors, who in Groundhog Day, is finally given opportunity to get the day “right”! The cost of repeating drug development is astonishing and the farther along the process you move, the higher the costs; this is the reason to do cutting edge, less expensive research more extensively in the early stages.
So how does drug development go through such a long development cycle and still lack necessary data needed for approval? Some reasons may be unknown scientific information, unknown yet available technology, or uninformed managers and reviewers.
Renovo Neural realizes the challenges and hopes to help researchers. “We are investing in marketing our techniques and technology to support drug development for neuro-degenerative diseases. It is important to make industry aware of what is available to them earlier in the development process” expressed by Dr. Satish Medicetty, President of Renovo Neural. He adds, “We are interested in providing our partners and colleagues more information to allow them to make informed decisions earlier in discovery and preclinical stages so that the more expensive clinical stages really pay off.” Renovo has scheduled a webinar for August 29th, 2013, entitled “Moving Your MS Preclinical Pipeline with Reliable and Reproducible Preclinical Data” that will support this strategy for providing researchers an update to the advanced tools, techniques and data they have generated in their study of multiple sclerosis.
On average, big pharma will spend hundreds of millions of dollars to develop one drug into approval. While this high number includes all the research, monitoring and multi-country processing fees, it stresses importance of the investment and should have the equal planning perspective in place.
Some pharmaceutical companies, the Government and other notable Associations are realizing the need to look closer during the early stages. The NIH put a former Merck scientist in charge of the translational medicine institute and empowered him to fund further academic development of drugs that big pharma had abandoned, this time trying to find new uses for them. If we apply the 80/20 rule to pharma, we could be in better shape than the current statistics being published regarding drug failures. Anyone that has experienced a successful project knows that the majority of time was spent in the plan, not the execution. Part of the proposed plan is to make the industry aware of data that supports using new research models and technology.
Renovo Neural’s 3D-Electron Microscopy was brought in house to assist initially multiple sclerosis focused companies in evaluating drugs at preclinical stages beyond traditional preclinical studies. According to Dr. Satish Medicetty, “New levels of the cell’s ultra structure and interactions can be evaluated… Our customers submit cell and tissue samples and, in return, receive image stacks containing hundreds of sequential slices through their material. Afterwards, they gain a complete 3-dimensional profile of their sample with the nanometer resolution necessary to see cell ultra structure and interactions. Most importantly, customers receive the data within a few days after submission, compared to wait-times of several weeks to months when using alternative sources.”
Dr. Medicetty also adds “As we think further about 3D-EM technology, we offer our expertise to companies that have experienced recent turndowns by the FDA and are considering the repositioning of abandoned CNS related drugs; these could be good candidates for evaluation by 3D-EM. We believe this technology will be part of the success in bringing good neural-related products to market. 3D-EM will revolutionize sub-cellular analysis and is poised for rapid growth in basic, translational and diagnostic medical sciences.”
Considerations for 3D-EM Technology:
- Evaluation of in-licensing of new drugs
- Drug Repositioning
- Prior to expensive clinical trials